# K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Oct 8, 2008 after 62 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K934139 (1995). 44 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System, Volcano Corporation (2008) Summary page 2.
- K041134: Combomap Pressure and Flow System, Volcano Therapeutics, Inc. (2004) Summary page 2.
- K965140: Cardiometrics Wavewire/Wavemap Pressure System, Cardio Metrics, Inc. (1997) Summary page 2.
- K021219: Smartwire/Smartmap Pressure System, Jomed, Inc. (2002) Summary page 2.
- K963290: Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1997) Summary page 2.
- K965223: Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1998) Summary page 2.
- K031148: IN-Vision Imaging System, Jomed, Inc. (2003) Summary page 2.

## Most influential descendants
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own
- K150441: Volcano iFR Modality, iFR Scout feature (2015), 9 descendants of its own
- K170133: FFR V2.5 (2017), 5 descendants of its own

## Recalls of this device
- Sep 23, 2013 · Class II · Z-2045-2015: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Fl
- Aug 24, 2012 · Class II · Z-2345-2012: The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
- Jun 29, 2010 · Not classified · Z-0168-2011: Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may re

## Indications for use
The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm. ComboMapTM Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

Source page: https://510kreport.com/device/K082229
Methodology: https://510kreport.com/methodology